NCT00052468

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,742

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_3

Geographic Reach
4 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 25, 2014

Status Verified

June 1, 2014

Enrollment Period

6.9 years

First QC Date

January 24, 2003

Last Update Submit

June 24, 2014

Conditions

Fallopian Tube CancerOvarian Cancer

Keywords

stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerfallopian tube cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Survival time is calculated from the date of enrollment into the study until the date of death from any cause

    Whole Study Period

Secondary Outcomes (1)

  • Progression Free Survival

    Whole Study Period

Other Outcomes (1)

  • Quality of Life

    Whole Study Period

Study Arms (2)

TCG

EXPERIMENTAL

Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses

Drug: TCG

TC

ACTIVE COMPARATOR

Paclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses

Drug: TC

Interventions

TCGDRUG
Also known as: Paclitaxel/Carboplatin/Gemcitabine
TCG
TCDRUG
Also known as: Paclitaxel/Carboplatin
TC

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of one of the following: * Ovarian epithelial cancer * FIGO stage IA/B G3, IC-IV * Fallopian tube cancer * Extra-ovarian papillary serous tumor * The following are ineligible: * Low malignant-potential ovarian tumors (borderline tumors) * Non-epithelial ovarian tumors * Mixed Mullerian tumors * Must have had definitive surgery within the past 6 weeks * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * WBC at least 3,000/mm\^3 OR * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 10 mg/dL Hepatic * Bilirubin no greater than 2 times upper limit of normal Renal * Glomerular filtration rate at least 50 mL/min Cardiovascular * No congestive heart failure * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart disease * No prior atrial or ventricular arrhythmias Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior seizures or central nervous system disorder * No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K) * No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel * No preexisting motor or sensory neuropathy greater than grade 1 * No other malignancy within the past 5 years except: * Malignancies cured by surgery alone * Carcinoma in situ of the cervix * Adequately treated basal cell skin cancer * No complete bowel obstruction * No other concurrent severe medical condition that would preclude study participation * No dementia or significantly altered mental status that would preclude study participation * No concurrent severe active infection * Geographically accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy except: * Hormone replacement therapy * Antiemetic steroids Radiotherapy * No prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * Recovered from prior surgery Other * No other concurrent antineoplastic agents * No other concurrent investigational drugs * No other concurrent clinical trial enrollment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (17)

Herlev Hospital - University Hospital of Copenhagen

Copenhagen, DK2730, Denmark

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Zentralkrankenhaus

Bremen, D-28205, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, DOH-40217, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Staedtische Kliniken Frankfurt am Main - Hoechst

Frankfurt, D-65929, Germany

Location

Frauenklinik der MHH

Hanover, 30659, Germany

Location

Vincentius Krankenhaus

Karlsruhe, D-76137, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, 39108, Germany

Location

Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

Munich, D-81377, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster

Münster, D-48129, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Universitaet Ulm

Ulm, D-89075, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Related Publications (2)

  • du Bois A, Herrstedt J, Hardy-Bessard AC, Muller HH, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelic S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol. 2010 Sep 20;28(27):4162-9. doi: 10.1200/JCO.2009.27.4696. Epub 2010 Aug 23.

    PMID: 20733132RESULT

  • Machelon V, Gaudin F, Camilleri-Broet S, Nasreddine S, Bouchet-Delbos L, Pujade-Lauraine E, Alexandre J, Gladieff L, Arenzana-Seisdedos F, Emilie D, Prevot S, Broet P, Balabanian K. CXCL12 expression by healthy and malignant ovarian epithelial cells. BMC Cancer. 2011 Mar 16;11:97. doi: 10.1186/1471-2407-11-97.

    PMID: 21410972DERIVED

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

PaclitaxelCP protocol

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Andreas du Bois, MD, PhD

    Dr. Horst-Schmidt-Kliniken

    STUDY CHAIR

  • J. Herrstedt

    Copenhagen County Herlev University Hospital

    STUDY CHAIR

  • E. Pujade-Lauraine, MD, PhD

    Hotel Dieu de Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

August 1, 2002

Primary Completion

July 1, 2009

Study Completion

January 1, 2011

Last Updated

June 25, 2014

Record last verified: 2014-06

Locations

FR(1)DK(1)DE(14)NO(1)